Pages

Friday, July 29, 2011

Is Robotic Surgery All Hype and No Substance

I am unable to contain myself for another minute. Let’s talk about robotic surgery.

This is from How Stuff Works, a Discovery Company, but it could have been written by the makers of the surgical robot:

“Most surgeries require nearly a dozen people in the room. As with all automation, surgical robots will eventually eliminate the need for some personnel.”

This is another example of a “straw man.” [Establish a false premise and defeat it with your argument.] Just about all operations require five people—surgeon, assistant, scrub nurse, circulating nurse, anesthesiologist. Some complex procedures might require another assistant. A dozen people might be needed for separation of Siamese twins or bilateral leg transplants.

There are many theoretical advantages of robotic surgery over conventional laparoscopy such as elimination of hand tremors, availability of more flexible instruments, more precise movements, easier learning and execution of intra-corporeal suturing techniques and possibly others. Disadvantages include the costs associated with robotic technology with the robotic itself selling for $1-2 million, yearly service contracts of >$300,000 and the high cost of the specialized instruments. Also, robotic surgery takes much longer than conventional surgery.

The problem with robotic surgery is that it has never been shown to improve patient outcomes for any procedure. Let’s look at the literature. The review articles cited below are almost exclusively based on non-randomized studies.

Laparoscopic Cholecystectomy. A review by the noted Cochrane Group involving five studies and 453 patients showed no differences in any outcome measure when comparing robotic surgery to conventional laparoscopic surgery.

Esophageal Reflux Disease. A review of 11 papers comparing standard laparoscopic anti-reflux surgery to Robot-Assisted Laparoscopic Fundoplication [acronym “RALF”] in 533 patients showed no differences in peri-operative complication rates or length of hospital stay. The robotic procedure took significantly longer. Another recent paper demonstrates the lack of quality research on this topic.

Colorectal Surgery. A review of 17 studies, one of which was randomized and controlled, showed no difference in the rates of complications and cancer outcomes. Robotic procedures took longer an cost more than conventional laparoscopic colon surgery. Despite the results, the authors felt that “Robotic colorectal surgery is a promising field and may provide a powerful additional tool…”

Gynecologic Surgery. A review of 22 non-randomized studies found that robotic surgery resulted in less blood loss [statistically significant but not clinically significant differences] and shorter hospital stays but no differences in overall complication rates when compared to conventional laparoscopic or open surgery. The authors commented that the methods used in the papers reviewed were poor and better studies are needed before concluding that robotic surgery offered any true advantages.

Abdominal Surgery. A paper from 2010 looked at 31 studies of nine different abdominal operations [robotic vs. conventional laparoscopic], 6 of which were randomized, controlled trials [RCTs]. The total number of patients included in all the studies was 2166. The number of patients who were participants in RCTs was 230. No RCT involved more than 50 patients. Not surprising was that the results were mixed with robotic surgery offering no clear advantage. These authors also called for larger and better designed studies.

Prostate Cancer. To date, there are no good RCTs comparing robotic to open or standard laparoscopic prostatectomy. This quote from a recent review of the literature on prostate cancer surgery says it all:

“Robotic prostatectomy is definitely here to stay and although a randomized, controlled trial comparing the open to robotic techniques would be ideal, it is clear that this is unlikely to occur.”

UPDATE[9/17/2011]Robotic hysterectomy outcomes are no better than standard procedures reports a new study. It also suggests the procedures are driven by marketing.

UPDATE [12/29/2011]Add gastrectomy to the list of procedures that do not show better outcomes when done robotically.

UPDATE [1/3/2012]ENT surgeon, @FauquierENT, dismisses robotic surgery for sleep apnea as "way overkill akin to using a $50,000 sniper rifle to kill an ant on the wall."

The issue may already be settled. According to the New York Times, patients are voting with their feet, preferring to have robotic surgery when it is available. This appears to be true in Wisconsin as well. A recent paper reveals that when hospital purchase a robot, their volume of prostate cancer surgery doubles.

Questions. Can anything be done about this? Should Medicare and private insurance companies pay for expensive, unproven treatments?

18 comments:

Anonymous
said...

A well known hospital in Southern CA and the surgeon will probably paying quite a lot for one of their robotic prostatectomies. A relative via marriage had robotic prostatectomy and died ~10 days post op - I suspect due to perfed bowel not seen during surgery. Pain disregarded at f/u visit, then distension -> AKF -> re-op -> ARDS -> MSOF -> death. Litigation pending. But hey, if he had survived he would have had a nerve sparing surgery done by a robot.

Obviously, robotic surgery isn't here to stay in it's current form, although costs and operation time can probably be driven down in the future. Those studies say that they aren't viable YET, but some day they might be.

Problem is lack of RCTs to justify the use of the robot. The technology is being driven by hype. It creates a desire for robotic surgery in the patients. Read the comment by the urologist who doesn't offer it in the NY Times link in my post.

A point I would like to make is that most studies are performed in a way that will lead to certain results. For example, comparing experienced open surgery by experienced surgeons vs. robotic surgeons performed by not as experienced surgeons will lead to outcomes more likely to be in favor of the more experienced surgeons.

I think the most important factor is the surgeon and his/her experience and not the way the procedure is going to be performed.

That being said, with my experience of hundreds of open and laparoscopic urologic procedures prior to performing robotic surgery, I personally see an improvement in my outcomes performing robotic surgery. The largest benefit are in the higher average blood loss procedures (radical and simple prostatectomy) or more complex procedures (partial nephrectomy).

The reason why this would make sense is the magnification allows me to see more detail than open surgery, the 3d is an advantage over laparoscopy, and in short, the procedure is easier and more comfortable for me to perform. In general, if things are easier to do, they will be done more accurately.

I do wish as scalpel points out that studies would be done since my opinion is that some surgeries are not complicated enough to warrant the extra expense of a robot. The actual expenses would need to be looked at as well as the outcomes.

Excellent post! Thanks also to a very informed perspective by Dr Savatta.

We in health care understand two basic premises: As patients we should be informed. As doctors we should be skeptical of adopting new technology until research has demonstrated improvements in clinical outcomes.

It is my understanding that insurance (or patient) pays no more for robotic assisted surgery than they would for traditional laparoscopic surgery. I circulate for both traditional laparoscopic and robotic assisted surgery. The only information that I have to go on is what I hear the surgeons say. One gynecologist has stated that her patients go home sooner and do better with robotics that traditional laparoscopic and definately better than open. I work with a bariatric surgeon that trained on the robot in fellowship and dislikes it immensely. However, watching her work laparoscopically, she does not need the robot.

From my standpoint, starting and finishing a robotic procedure is much more labor intensive than laparoscopic. In the 1980's it was never though that laparoscopic procedures would ever gain favor. And it was unheard of a 30 minute skin to skin lap chole. What would have happened if the nay-Sayers had gotten their way about laparoscopic procedures then? Robotics is gaining ground. Those that do it often are getting better and faster.

Thanks for the comment. Maybe where you are insurance doesn't pay extra. If not, then your hospital is eating the $2000-3000 worth of disposable supplies and the yearly fee of ~$150,000.

Your anecdotes are interesting and your point about laparoscopic surgery in the beginning is a good one, but in the era of evidence-based medicine, let's see some proof that the robot is better for patient outcomes.

As someone who had the thyroid removed just prior to the employment of robotic surgery I used to wonder which procedure was better. Over time I’ve somehow gotten the impression the standard surgery I went through was probably best. One particular video from orlive.com has helped me see this. It’s of a surgeon performing thyroid surgery where at about twelve minutes into it he is asked why he has chosen to perform standard surgery. Here’s the address to that video:

Obviously, robotic surgery isn't here to stay in it's current form, although costs and operation time can probably be driven down in the future. Those studies say that they aren't viable YET, but some day they might be.

I am not a Doctor, I am just a woman who in 2011 was suppose to have Laparoscopic Cholocystectomy, (gallbladder), and instead of 3 to 4 little holes, I awoke to a cut from my breast bone down to my pubic bone. I don't know what really happened because i was told there was no video, but if what you Doctors are saying is true then why is there no video. and as for data on this subject, money and the amount of data should not even matter it is suppose to be about doing no harm to your patient. Now I understand that accidents do happen, but when all that has become important is moneyand data then harm does acure to the patient. When I am told before the surgery by the Surgeon that he may not be able to do the Laparoscopic due to scarring from my previous abdominal surgeries, and that if the scarring was to extensive he would then have to convert it to an open cholocystectomy. Can someone then please tell me HOW does he lacerate my part or branch of my aorta back by my lower left spine? Considering my gallbladder is on my right side and a human did this then maybe you all should consider human assisted surgeries instead of robotic assisted. If a patient needs the data on their surgery, they should be given it to help them heal, they should not have to jump through 20 million hoops to try to aquire it. I am someones daughter, child, mother , sister, and I have incurred much harm and so has my family. I did not even hear from not one Doctor an "i am sorry". instead I was billed, harrassed, mentally, physically,and emotionally hurt, and basically given the finger. I now have such fear of doctors that my nipple is now starting to dimple and I wont go to get it checked. So let me ask you all this, When is it right for a doctor to preform a surgery that he knew he may not be able to safely preform with the intended result? Is that not causing Harm? I have never had anything that this Doctor did really explained to me, I am severly damaged emotionally mentally, and physically. Why does he walk away unscathed while i sit here wondering what can I expect next? Is it because he is a Doctor, and I am just some small town girl? Thank you for your time.

I am sorry that this happened to you. I can't explain why the surgeon did what he did. I assume your injury occurred with the insertion of a trocar which is like a small tube through which the instruments and camera are inserted.

I am not one to advocate lawsuits, but if you could not get your questions answered to your satisfaction, then a suit might have been the only way to do so. I don't know what state you are in, but the statute of limitations has probably expired since the surgery was in 2011. Only a lawyer could advise you about that.

New onset of dimpling of a nipple can be a sign of a tumor. You should have a breast exam and a mammogram as soon as possible.

Suzanne Sez2 Yes that is why. There are built in protections: from risk managers who do this all the time, to hospital admin with the $$$ to back up them and lawyers to wear you out of $$$. State Medical Boards that have conflicts of interests and buddies, where the lack of doing anything is typical. Legislators who don't care about enacting legislation that has serious consequences for things like this.